510(k) K210366 ยท LZA Polymer Patient Examination Glove
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
| Applicant | Onetexx Sdn Bhd, Kamunting, MY |
| Decision | Substantially Equivalent, May 7, 2021 |
| Received | Feb 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210366
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.